NA

Basic Information

• Brand Name: NA
• Primary DI: 00613994871510
• Version / Model: SRE1002
• Company Name: MEDTRONIC XOMED, INC.
• Labeler DUNS: 835465063
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-05
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: fe568dc5-ce54-4b5d-be40-ae78be009a3b

Device Description

ELECTRODE SRE1002 SD SURFACE RECORD ROHS

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE	Neurology	882.1900	2
GWE	STIMULATOR, PHOTIC, EVOKED RESPONSE	Neurology	882.1890	2
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE	Neurology	882.1870	2
ITX	Transducer, ultrasonic, diagnostic	Radiology	892.1570	2
IYN	System, imaging, pulsed doppler, ultrasonic	Radiology	892.1550	2
GWQ	Full-montage Standard Electroencephalograph	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47714	Subdermal needle electrode	A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient's skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994871510	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K061639	000

Device Sizes

Type	Value	Unit	Text
Length	2.5	Meter
Length	13.0	Millimeter
Width	20.0	Millimeter
Length	27.0	Millimeter
Needle Gauge	27.0	Gauge

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 41 – 86 Degrees Fahrenheit